Food Laws and Regulations

Mata Kuliah
Sanitasi Industri Perikanan

Bayu Kusuma, S.Pi, M.Sc

Teknologi Hasil Perikanan
Fakultas Perikanan dan Ilmu Kelautan
Universitas Brawijaya
2015

Buku bahan ajar

Troller, J.A. 1983. Sanitation in Food Processing.
Academic Press: New York.

Daftar Isi
Law
Enforcement
Impact of Regulation

History
Pada masa yang lalu, konsumen akan dengan mudahnya
merasa puas dengan makanan yang terlihat aman serta
berbau dan berasa enak.
Sekarang, konsumen mengetahui bahwa banyak komponen
yang berbahaya efeknya bagi kesehatan sehingga trust dari
konsumen membutuhkan sebuah law dan regulation.
Banyak organisasi yang mengatur regulasi dan hukum tentang
pangan didirikan guna perlindungan konsumen seperti FDA,
WHO, dsb.

The Federal Food, Drug, and Cosmetic Act of 1938

It contains added poisonous or added deleterious substances
that may render it injurious to health.
It bears or contains any added poisonous or added deleterious
substance that is unsafe.
It consists in whole, or in part, of any filthy, putrid, or
decomposed substance, or if it is otherwise unfit for food.
It has been prepared, packed or held under unsanitary
conditions whereby it may have become contaminated with
filth or whereby it may have been rendered injurious to
health.

TIME TO THINK AND

DISCUSS

FDA Inspectors
1. Present credentials to appropriate company officials.
2. Provide written notice of inspection [Form 482].
3. After the inspection has been completed, a written statement
covering any violative conditions [Form 483] must be
presented to the offending company.
4. Receipts [Form 484] must be furnished for any samples
obtained. Samples must be paid for by the FDA.
5. In some cases, such as low-acid canned foods, a written
request for certain records may be used.
6. In similar instances to number 5, a written request for
information on procedures and processes also may be
submitted.

Outcome Inspections
1. Nothing. Your plant is picture-book perfect or the inspector
missed a few little "problems" that you were holding your
breath over.
2. Regulatory letter informing you of unsatisfactory conditions
and requesting appropriate corrections.
3. Reinspection within some designated period of time.
4. Seizure of adulterated or misbranded products.
5. Hearing on possible criminal proceedings.
6. Recall.
7. Criminal prosecution.
8. Federal court order prohibiting violative acts.

Notice of Adverse Findings

Surat informasi mengenai kecurigaan terhadap kondisi atau
produk yang melanggar hukum dalam sebuah industri
makanan.
Kriteria dikeluarkannya Notice of Adverse Findings adalah:
1.
2.
3.

Violation of the law has occurred or there is evidence that an existing

practice may lead to a violation if not corrected.
The history of the case indicates that there is a likelihood of prompt
and complete correction.
The agency has elected to request voluntary action and has not made
a final decision to seek formal administrative or judicial relief if a
correction is not effected.

Regulatory Letters
Surat pemberitahuan terhadap kondisi atau produk yang
melanggar hukum setelah dilakukannya proses inspeksi dalam
sebuah industri makanan.

Seizure
Merupakan sebuah tindakan untuk menarik semua produk
yang ada di pasaran.

Injuction
Merupakan sebuah larangan yang dikeluarkan oleh
pengadilan untuk melarang distribusi makanan yang
melanggar hukum.

Market Recoveries
Stock recovery.
Market withdrawal.
Recalls. Types issue for recalls:
1.
2.

3.

Class I. There is a reasonable expectation that use of or exposure to a

violative product will cause serious health risks or death.
Class II. Use of or exposure to a violative product may cause
temporary or medically reversible adverse health consequences, or
the probability of serious, adverse health consequences is remote.
Class III. A situation in which use of or exposure to a violative product
is not likely to cause adverse health consequences.

TIME TO THINK AND

DISCUSS

Exports and Imports Regulations

Food Defect Action Levels 1

Food Defect Action Levels 2

Impact of Regulation
Cost
Safety
Effect on product development. Consideration on product
development:
1.
2.
3.
4.
5.

What the product is to be. Is a common name for it established?

Ingredientsdietary considerations and definition of standard
Ingredients. Amounts of ingredients. Are they restricted?
Size of marketing unit. Identify reasonable serving portions and their
proportion of the recommended daily allowance.
Consumer concept of the product. Is it represented honestly?

GMP (Good Manufacturing Practices)

The GMP regulations were established in 1969 to define in
clearer terms what the FDA expects from food plants that
meet the provision of the Food Drug and Cosmetic Act of
1938, which essentially states that a food is considered
adulterated if it has been packed, held, or prepared under
conditions in which it might have become contaminated.
The GMPs are an attempt to delineate what these conditions
are and as such, are an aid to industry by directing attention
toward what the FDA looks for with regard to sanitation.

TIME TO THINK AND

DISCUSS

TERIMA KASIH